Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Camurus AB
• Collaborator: Novartis
• Treatments: Octreotide

Criteria

Inclusion Criteria:

Acromegaly:

• Male or female patients ≥18 years of age

• Acromegaly currently treated with Sandostatin LAR

NET:

• Male or female patients ≥18 years of age

• Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid syndrome (number of bowel movements and/or flushing)

• Currently treated with Sandostatin LAR for symptom control

Exclusion Criteria:

Acromegaly:

• Inadequate bone marrow function

• Abnormal coagulation or chronic treatment with warfarin or coumarin derivates

• Impaired liver, cardiac and/or renal function

• Known gallbladder, bile duct disease or pancreatitis

• Diabetes with poorly controlled blood glucose levels despite adequate therapy

• Hypothyroidisms not adequately treated

NET:

• Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine carcinoma and small cell carcinoma

• Carcinoid syndrome refractory to treatment with conventional doses of somatostatin analogues (SSAs)

• Inadequate bone marrow function

• Abnormal coagulation or chronic treatment with warfarin or coumarin derivates

• Impaired liver, cardiac and/or renal function

• Known gallbladder, bile duct disease or pancreatitis

• Short-bowel syndrome

• Diabetics with poorly controlled blood glucose levels despite adequate therapy

• Hypothyroidism, not adequately treated